The Efficacy of Individualized Dietary Advice in Improving Diet Quality and Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Difference in Mean Change in Prime Diet Quality Score Between Groups Between Months 0 and 6
研究概览
简要总结
This study is a a randomized controlled parallel group dietary intervention conducted over six months in participants at high risk of cardiovascular disease living in Ireland (North and South) to evaluate the efficacy of individualized dietary advice incorporating biomarker profiles in improving diet quality and cardiometabolic outcomes.
详细描述
Study design: a randomized controlled parallel group dietary intervention will be conducted over six months in participants at high risk of CVD living in Ireland (North and South) to evaluate the efficacy of individualized dietary advice incorporating biomarker profiles in improving diet quality and cardiometabolic outcomes.
Population and recruitment
Population characteristics: Participants will be at high risk (>20% over 10 years) of developing CVD. Established recruitment mechanisms, used in several previous and ongoing dietary intervention studies, from general practices, hospital outpatient clinics, and from the general population (via press release, radio interviews, poster placement) will be utilized.Recruitment will take place over an 18 month period.
Inclusion criteria: Participants will be considered eligible to enroll in the study if they are overweight (BMI >27 and ≤ 45 kg/m2), have low Prime Diet Quality Score (PDQS <15)27 and a combination of risk factors which places them at high total risk (estimated multifactorial CVD risk ≥ 20% over ten years) of developing atherosclerotic CVD for the first time.
Exclusion criteria: Participants will be ineligible to enroll in the study if they have established diabetes mellitus, CVD or a medical condition or dietary restriction(s) that would substantially limit their ability to complete the study requirements, have an excessive alcohol consumption (>28 Units/week for men or >21 Units/week for women), have a low predicted likelihood to change dietary habits or are unable to provide informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
All outcomes will be conducted blind, including the primary outcome (diet quality score), laboratory analysis and cardiometabolic health marker assessment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be considered eligible to enroll in the study if they are:
- •overweight (BMI >27 and ≤ 45 kg/m2),
- •have low Prime Diet Quality Score (PDQS <15) and
- •have a combination of risk factors which places them at high total risk (estimated multifactorial CVD risk ≥ 20% over ten years) of developing atherosclerotic CVD for the first time.
排除标准
- •Participants will be ineligible to enroll in the study if they have:
- •established diabetes mellitus, CVD or a medical condition or dietary restriction(s) that would substantially limit their ability to complete the study requirements,
- •have an excessive alcohol consumption (>28 Units/week for men or >21 Units/week for women),
- •have a low predicted likelihood to change dietary habits
- •are unable to provide informed consent.
结局指标
主要结局
Difference in Mean Change in Prime Diet Quality Score Between Groups Between Months 0 and 6
时间窗: Baseline and six months
Dietary quality will be assessed using an online version of the Prime Diet Quality Score (PDQS). Foods are classified as healthy and unhealthy. Points are assigned according to the following criteria: 0-1 serving/wk (0 point) compared with 2-3 servings/wk (1 point) compared with ≥4 servings/wk (2 points) for the healthy food groups. Scoring is reversed and points deducted for the unhealthy food groups. Points for each food group are summed to give an overall score. The PDQS has 21 food groups and ranges from 0 to 42 total score (scores on a scale), with a higher score indicating a better diet quality.
次要结局
- Alcohol Consumption(Baseline and six months)
- Medication Use(Baseline and six months)
- Physical Activity(Baseline and six months)
- Anthropometric Data - Weight(Baseline and six months)
- Anthropometric Data - Waist to Hip Ratio(Baseline and six months)
- Anthropometric Data - Height(Baseline and six months)
- Blood Pressure(Baseline and six months)
- Biomarkers of Diet Quality(Baseline and six months)
- Gut Microbiota Composition (Subset of Participants Only)(Baseline and six months)
- Anthropometric Data - Body Composition.(Baseline and six months)
- Biomarkers of Cardiometabolic Risk(Baseline and six months)
研究者
Jayne Woodside, PhD
Professor
Queen's University, Belfast